TPLC - Total Product Life Cycle

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Device	transcranial magnetic stimulator
Definition	A transcranial magnetic stimulator is a device that delivers brief duration, rapidly alternating, or pulsed, magnetic fields to induce electrical currents that are directed at spatially discrete regions of the cerebral cortex for the treatment of major depressive disorder.
Product Code	OBP
Regulation Number	882.5805
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	71	71
Insufficient Information	29	29
Patient-Device Incompatibility	24	24
Patient Device Interaction Problem	9	9
Improper or Incorrect Procedure or Method	5	5
Output Problem	4	4
Therapeutic or Diagnostic Output Failure	2	2
Product Quality Problem	2	2
Unexpected Therapeutic Results	2	2
Energy Output Problem	2	2
Device Alarm System	1	1
Unintended Electrical Shock	1	1
Smoking	1	1
Output above Specifications	1	1
Use of Device Problem	1	1
Use of Incorrect Control/Treatment Settings	1	1
Defibrillation/Stimulation Problem	1	1
Malposition of Device	1	1
Off-Label Use	1	1
Appropriate Term/Code Not Available	1	1
Loss of Power	1	1
Loose or Intermittent Connection	1	1
Device Displays Incorrect Message	1	1
Noise, Audible	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Anxiety	53	53
Headache	50	50
Depression	36	36
Tinnitus	36	36
Pain	31	31
Cognitive Changes	28	28
Suicidal Ideation	28	28
Sleep Dysfunction	26	26
Convulsion/Seizure	26	26
Emotional Changes	21	21
Dizziness	19	19
Memory Loss/Impairment	17	17
Fatigue	14	14
Nausea	13	13
Twitching	10	10
Irritability	8	8
Hearing Impairment	7	7
Confusion/ Disorientation	7	7
Vertigo	7	7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	7	7
Brain Injury	7	7
Weight Changes	6	6
Unspecified Mental, Emotional or Behavioural Problem	5	5
Unspecified Eye / Vision Problem	5	5
Speech Disorder	5	5
Seizures	5	5
Cramp(s) /Muscle Spasm(s)	4	4
Blurred Vision	4	4
Hypersensitivity/Allergic reaction	4	4
Increased Sensitivity	4	4
Decreased Appetite	4	4
Balance Problems	3	3
Visual Impairment	3	3
Numbness	3	3
Loss of consciousness	3	3
Retinal Tear	3	3
Lethargy	3	3
Palpitations	3	3
High Blood Pressure/ Hypertension	3	3
Visual Disturbances	3	3
Tachycardia	2	2
Undesired Nerve Stimulation	2	2
Bradycardia	2	2
Shaking/Tremors	2	2
Therapeutic Response, Decreased	2	2
Hair Loss	2	2
Unspecified Heart Problem	2	2
Discomfort	2	2
Sensitivity of Teeth	2	2
Diarrhea	2	2